Quality Of Life Questionnaire Of The European Foundation For Osteoporosis Research Articles

Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.

Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.

Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.

Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.

Percutaneous Vertebroplasty Versus Conservative Treatment in Aged Patients With Acute Osteoporotic Vertebral Compression Fractures: A Prospective Randomized Controlled Clinical Study.

A prospective randomized clinical trial. In this study, we determine whether percutaneous vertebroplasty (PVP) offers extra benefits to aged patients with acute osteoporotic vertebral compression fractures (OVCFs) over conservative therapy (CV). OVCFs are common in the aged population with osteoporosis. While the optimal treatment of aged patients with acute OVCFs remains controversial, PVP, a minimally invasive procedure, is a treatment option to be considered. Patients aged at 70 years or above with acute OVCF and severe pain from minor or mild trauma were assigned randomly to PVP and CV groups. The primary outcome was pain relief as measured by VAS score in 1-year follow-up period. The second outcome was quality of life assessed with ODI and Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Patient satisfaction surveys were also recorded. A total of 135 patients were enrolled, and 107 (56 in PVP group; 51 in CV group) completed 1-year follow-up. In PVP group, the vertebroplasty procedure was performed at a mean of 8.4 ± 4.6 days (range, 2-21 days) after onset. Vertebroplasty resulted in much greater pain relief than did conservative treatment at postoperative day 1 (P < 0.0001). At every time point of follow-up, pain relief and quality of life were significantly improved in PVP group than in CV group at 1 week, 1 month, 3 months, 6 months, and 1 year (all P < 0.0001). The final follow-up surveys indicated that patients in PVP group were significantly more satisfied with given treatment (P < 0.0001). In addition, lower rate of complications was observed in PVP group (P < 0.0001). In aged patients with acute OVCF and severe pain, early vertebroplasty yielded faster, better pain relief and improved functional outcomes, which were maintained for 1 year. Furthermore, it showed fewer complications than conservative treatment. 2.

Unilateral or bilateral percutaneous vertebroplasty for acute osteoporotic vertebral fracture: a prospective study.

Percutaneous vertebroplasty (PVP) has been demonstrated to be effective in the treatment of acute osteoporotic vertebral fracture (AOVF). However, the matter of which surgical approach should be selected remains controversial. This research aims to compare the clinical results of unilateral and bilateral PVP for AOVF. From January 2008 to December 2011, 68 patients with AOVF were randomly assigned to the unilateral puncture group (n=36) or the bilateral group (n=32). These patients underwent percutaneous injection of polymethyl methacrylate into posterior pedicle by the unilateral or bilateral puncture approach. Visual analogue scale (VAS) and the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) were recorded on presentation, at 1 week, 3, 6, and 12 months after operation. The cement leakage was measured by x-ray and computed tomography scan. Follow-up data showed there were no significant differences in VAS and QUALEFFO between 2 groups at 1 week after PVP and only significant difference was observed between 2 groups at 3, 6, and 12 months after operation. The cement leakage was 52.7% in the unilateral puncture group and 28.1% in the bilateral group. Compared with unilateral puncture, use of bilateral approach during PVP may result in more superior long-term outcomes and less cement leakage for patients with AOVF.

Teriparatide vs. Alendronate as a treatment for osteoporosis: Changes in biochemical markers of bone turnover, BMD and quality of life

SummaryBackgroundWe studied the use of teriparatide in postmenopausal women with severe osteoporosis.Material/MethodsTwo groups (A and B) of patients affected by severe osteoporosis (T-score ⩽−2.5 at bone mineral density were analyzed and 2 vertebral fractures on radiograph).Group A was treated for 18 months with 20 μg/day of teriparatide. Group B was treated with bisphosphonates 70 mg/week. Every woman assumed 1 g of calcium and 800 IU of vitamin D3 daily. We evaluated the effects of therapy after 18 months (T18) from the beginning with bone turnover markers (alkaline phosphatase, procollagen type 1 N-terminal propeptide, and N-telopeptide cross-links) and dual-energy X-ray absorptiometry.ResultsGroup A, at T18 procollagen type 1 N-terminal propeptide levels, increased 127%; bone alkaline phosphatase levels increased to 65%; N-telopeptide cross-links levels increased to 110%.Group B, at T18 procollagen type 1 N-terminal propeptide levels, decreased to 74%; bone alkaline phosphatase levels decreased to 41%; N-telopeptide cross-links levels decreased to 72%.After 18 months, lumbar bone mineral density increased to 12.4% and femoral bone mineral density increased to 5.2% in group A. Group B lumbar bone mineral density increased to 3.85% and femoral bone mineral density increased to 1.99%. Only a new vertebral fracture occurred in group A (2.4%), whereas 6 fractures occurred in group B (15.7%).The quality of life questionnaire of the European Foundation for Osteoporosis (QUALEFFO) revealed a significant improvement in daily living, performed domestic jobs, and locomotor function in groups A and B.ConclusionsThe use of rhPTH in patients with severe osteoporosis offers more protection against fractures and improves the QoL more than bisphosphonates.

Capacitively Coupled Electric Field for Pain Relief in Patients with Vertebral Fractures and Chronic Pain

Fragility vertebral fractures often are associated with chronic back pain controlled by analgesic compounds. Capacitive coupling electrical stimulation is a type of electrical stimulation technology approved by the US FDA to noninvasively enhance fracture repair and spinal fusion. These uses suggest it would be a possible treatment for patients with back pain attributable to vertebral fractures. We therefore randomized 51 postmenopausal women with multiple fractures and chronic pain to the use of one of two indistinguishable devices delivering either the standard capacitive coupling electrical stimulation by Osteospine (active group) or low intensity pulse (control group). Twenty patients of the active group and 21 of the control group (80%) completed the study for a total duration of 3 months. The mean visual analog scale values for pain and the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) scores improved in both groups. We observed a relationship between hours of treatments and reductions in pain intensity only in the active group. Capacitive coupling electrical stimulation was not more effective than control treatment when comparing mean visual analog scale pain and QALEFFO scores in the two groups and when adjusting for the hours of treatment. However, the proportion of patients able to discontinue NSAIDs owing to elimination or reduction of pain was greater in the active group than in the control group. We interpret these findings as suggesting capacitive coupling electrical stimulation controls pain in some patients and reduces the use of NSAIDs. Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Validation of the English version of the quality of life questionnaire of the European Foundation for Osteoporosis (QUALEFFO) in Malaysia

AbstractBackground: Osteoporotic fractures will soon become a common problem in Asian countries including Malaysia, as the growth in the elderly population will be more marked in this region. This leads to loss of independence and reduced quality of life (QOL). QOL is used as an outcome measure in clinical trials to focus the management of diseases on the patient rather than the disease. To date, no such instrument for measuring QOL of osteoporosis patients has been validated in Malaysia.Aim: To investigate the reliability and validity of the English version of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) in Malaysia.Methods: QUALEFFO was administered twice to postmenopausal osteoporotic women on alendronate. The patient group consisted of 46 women with back pain while the control group consisted of 42 women without back pain.Results: High internal consistency was seen in all domains in the QUALEFFO with Cronbach α of 0.74–0.95 and 0.53–0.89 in the patient and control group, respectively. Factor analysis also showed that each domain consisted of one component except for the social domain. The test‐retest reliability showed high correlation coefficient in all domains (0.50–0.90, P &lt; 0.001). Patients with back pain showed significantly worse QOL in the overall total QUALEFFO score compared to the control group (P &lt; 0.0001).Conclusions: The English version of QUALEFFO was found to be reliable and valid for the evaluation of patients with osteoporosis and who understand English in Malaysia. This study also indicates that patients with back pain have poorer QOL.

Changes of the quality-of-life under the treatment of severe senile osteoporosis with teriparatide

Despite being treated with antiresorptive drugs, the severe osteoporosis (SO) is being considered as a condition in which patients are still subject to one or more vertebral or femoral fractures, or non-vertebral or non-femoral fractures, i.e., of other parts of the body such as the wrist, shoulder, tibia, ribs or hip. These patients are defined as non-responders (NRs) to the antiresorptive therapy, and recent research has shown that they represent 10–25% of all SO patients. During the last almost 3 years a new drug has become available in Italy, called teriparatide (rh-PTH-1-34), produced in Escherichia coli using the recombinant-DNA technique. It shows remarkable trophic and anabolic actions on the bones, and proved to be very useful for treating the osteoporosis in general. This study describes our experience in using teriparatide for the treatment of SO in a sample of 141 elderly women of mean age 73.4 ± 5.8 years, with a mean number of fractures of 3.0 ± 0.85, with a spine deformity index (SDI) of 5.92 ± 1.27 and a mean vertebral T-Score (L1–L4) of −3.15 ± 0.39, and a mean femoral T-Score of −2.50 ± 0.28. All these patients had been treated with antiresorptive drugs for at least 1 year: specifically 70 of them with Alendronate, 42 of them with Risedronate and 29 of them with Raloxifene. For 18 months, all these patients were injected subcutaneously with 20 μg of teriparatide, with the daily addition of 1 g of calcium and 880 IU of vitamin D. The study was continued for 24 months, at the end of which the patients continued to take only calcium and vitamin D. The patients underwent a CBM-DEXA control of vertebral column and femur every 6 months, and they were also administered a Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The QUALEFFO (41 items) questionnaire to evaluate the changes in the quality-of-life (QoL) and the consumption of non-steroidal anti-inflammatory drugs (NSAIDs) was also recorded. The results showed that teriparatide protected 96.5% against new fractures (only five new fractures occurred), bone mineral density (BMD) increased approximately by 12% in the vertebral column and by 11% in the femur, consumption of NSAIDs was reduced at the early stage approximately 80%, the QoL improved considerably and remained so during the 18 months of teriparatide treatment, with only a slight decrease during the 6 subsequent months.

Cultural adaptation and validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) in a Mexican population

Measuring quality of life (QOL) is important, but to date, questionnaires to measure QOL in Mexican patients with osteoporosis (OP) have not been validated. A study was carried out to culturally adapt and validate the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) in a Mexican population. Interviews were performed with 160 women, 80 patients with at least one vertebral fracture, and 80 patients with OP as determined by the World Health Organization criteria. Several cultural modifications were made to the Spanish version of the QUALEFFO. Content validity was assessed by a group of experts, and a pilot study was undertaken. At the same time, the Spanish version of the Short Form 36 (Medical Outcomes Study) was applied. The mean age of patients was 71.9 +/- 11.1. The QOL questionnaire showed a test-retest reproducibility (R (i) = 0.94) and internal consistency (alpha = 0.92), while social function scored low (alpha = 0.46). Concurrent validity was significant (r = -0.837, p < 0.001). Significant differences were found between the two groups for pain (p < 0.05), physical function (p < 0.01), social function (p < 0.01), mental function (p < 0.05), and number of fractures (p < 0.001). Discriminatory characteristics between the groups were significant for physical (p < 0.001), social (p < 0.001), and mental (p < 0.02) function. The cultural adaptation of the QUALEFFO was consistent, homogenous, and discriminative. It also showed deterioration in the QOL group of Mexicans with vertebral fractures. The QUALEFFO can be used in a Mexican population to measure the QOL in patients with vertebral fractures after some cultural modifications to take into account local sensibilities.

The Management of Pain From Collapse of Osteoporotic Vertebrae With Continuous Intrathecal Morphine Infusion

Objectives. Vertebral fractures are the most common consequences of severe osteoporosis. The chronic pain from collapse of osteoporotic vertebrae affects quality of life (QoL) and autonomy of patients. The management of pain with oral or transdermal opiates can cause severe side-effects. Continuous intrathecal administration of morphine through an implantable pump might represent an alternative therapy to conventional oral or transdermal administration of opioids and has some advantages and disadvantages for pain relief and improvement in QoL when compared to conventional opioid delivery. It is our objective to report our experience using intrathecal delivery of analgesics in a population of patients with refractory pain due to vertebral fractures. Materials and Methods. In 24 patients, refractory to conventional delivery of opioids, we used intrathecal analgesic therapy. To test for efficacy and improvement in QoL, we administered the visual analog scale (VAS) for pain and the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Before patients were selected for pump implantation, an intraspinal drug delivery trial was performed to monitor side-effects and responses to intrathecal therapy. Results. Significant pain relief was obtained in all implanted patients. Using the QUALEFFO, we observed significant improvement of all variables such as QDL (quality of daily life), DW (domestic work), ambulation, and PHS (perception of health status), before and after oneyear after pump implantation. With intrathecal morphine infusion, none of the 24 patients required additional systemic analgesic medication. The mean morphine dose during the spinal trial was 11.28mg/day, 7.92mg/day at pump implantation, and 16.32mg/day at one-year follow-up. Conclusions. Our results show that intrathecal administration of morphine efficiently relieves the symptoms of pain and improves QoL. Continuous intrathecal administration of morphine appears to be an alternative therapy to conventional analgesic drug delivery and has advantages in those patients who have severe side-effects with systemic administration of analgesics.

High prevalence of asymptomatic vertebral fractures in post-menopausal women receiving chronic glucocorticoid therapy: A cross-sectional outpatient study

Glucocorticoid (GC)-induced osteoporosis mostly affects trabecular bone of vertebrae. Only 30% of vertebral fractures are symptomatic, yet both clinical and radiological vertebral fractures have been associated with increased mortality and morbidity. The aims of this cross-sectional, outpatient-based study were to measure the prevalence of asymptomatic vertebral fractures in a large sample of post-menopausal women given GCs for different diseases; to compare prevalence of asymptomatic vertebral fractures according to disease, GC treatment and major risk factors; and to assess the quality of life in GC users with and without asymptomatic vertebral fractures. 551 patients referring to 39 centers as outpatients for their programmed follow-up and satisfying the inclusion criteria were included in the analysis. Each patient underwent structured medical interview (including dose and duration of GC therapy, major risk factors for osteoporosis, the quality of life questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and a back function score questionnaire), thoraco-lumbar radiographs and subsequent morphometry; for 253 and 437 patients, respectively, lumbar spine bone mineral density (BMD) assessed by dual energy X-ray absorptiometry and calcaneal bone stiffness assessed by quantitative ultrasonometry were available. The prevalence of asymptomatic vertebral fractures resulted >37%, with >14% of patients having two or more asymptomatic vertebral fractures and was much higher than that found in epidemiological studies on healthy women. Distribution of asymptomatic vertebral fractures along the spine showed a bimodal pattern, with two peaks at T7 and T11. The prevalence of asymptomatic vertebral fractures clearly increased with age. Differences in prevalence among diseases were evidenced. When controlled for age, GC cumulative dose, duration of therapy and personal history of fractures, the adjusted prevalences were 30.77% for systemic lupus erythematosus, 33.78% for rheumatoid arthritis, 37.78% for asthma/chronic obstructive pulmonary disease, 43.20% for polymyalgia rheumatica and 43.36% for diseases grouped as “other vasculitides/connective tissue diseases”. No significant association was found with GC cumulative dose and duration of therapy. Established risk factors for osteoporosis (except for age, years since menopause and personal history of fractures), lumbar spine BMD, calcaneal stiffness and QUALEFFO score were not associated with number and severity of asymptomatic vertebral fractures. Underlying disease is likely to contribute to the risk of fracture, but disease by itself could not be dissected from GC regimen. Vertebral fractures should be looked for carefully in all post-menopausal women receiving long-term systemic GCs since they can be asymptomatic and are scarcely predictable.

The reliability and validity of the Turkish version of Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO).

The purpose of this study was to investigate the reliability and validity of the Turkish version of Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The patient group included 43 females aged between 55 and 78 years with vertebral fractures due to osteoporosis. The control group consisted of 43 healthy female volunteers whose ages matched those of the patients. All of the participants were evaluated using both QUALEFFO and SF-36. In the reliability studies, internal consistency within the domain of QUALEFFO was generally good, with Cronbach's alpha values ranging between 0.70 and 0.96. Convergent and discriminant validity rates of domains were both found to be between 89% and 100%. Significant correlations existed between scores of similar domains of QUALEFFO and the SF-36, especially for pain, physical function, social function and general health perception. The receiver operating characteristic (ROC) curve analysis of QUALEFFO and the SF-36 indicated that all five domains in each questionnaire were significantly predictive of vertebral fractures. However, when comparing similar domains of the two questionnaires, the social function domain of QUALEFFO demonstrated a significantly better performance. In conclusion, the Turkish version of QUALEFFO was found to be reliable and valid in the evaluation of patients with vertebral fractures due to osteoporosis. Our study also suggests that the patients with vertebral fractures due to osteoporosis have impairment in quality of life.

Quality-of-life assessment in osteoporosis: health-status and preference-based measures.

Health-status and preference-based approaches to assessing health-related quality of life (HR-QOL) in osteoporosis are reviewed. Osteoporosis-targeted health-status instruments [i.e. Osteoporosis Quality-of-Life Questionnaire (OQLQ), Osteoporosis Assessment Questionnaire (OPAQ), Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO), Osteoporosis-Targeted Quality-of-Life Questionnaire (OPTQoL), Osteoporosis Functional Disability Questionnaire (OFDQ), Quality-of-Life Questionnaire in Osteoporosis (QUALIOST)], which have been utilised to document the adverse impact of osteoporosis on HR-QOL in diverse clinical and epidemiological studies, are described first. Preference-based approaches to osteoporosis health-outcome measurement are then considered in both clinical and health policy settings. In the clinical setting, direct preference assessments [i.e. visual analogue scale (VAS), time tradeoff (TTO), standard gamble (SG)] using either experienced or described health outcomes have consistently shown significantly lower values for osteoporosis-related health states relative to usual or ideal health. In the health-policy context, preference-classification systems [i.e. EuroQoL (EQ-5D), Health Utilities Index (HUI)] for valuing health in economic studies are reviewed. At present, there is little evidence to guide the choice of one system over another for assessing the cost effectiveness of osteoporosis interventions; however, use of a consistent set of health-state values is essential. Further research is needed to characterise associations between osteoporosis-targeted health-status instruments and preference-based health-outcome measures. In addition, the longitudinal impact of osteoporosis and related fractures on HR-QOL must be documented.

A 10-WEEK EXERCISE INTERVENTION IMPROVES BALANCE IN 65???75 YEAR OLD WOMEN WITH OSTEOPOROSIS

Recurrent falling is an independent risk factor for osteoporotic fracture. Many risk factors for falling have been identified these include muscle weakness, and impaired balance. Physical activity has been shown to improve muscle strength and coordination and thus may reduce the risk of falling and subsequent fracture. Yet there have been very few randomized controlled trials employing an exercise intervention in women with proven osteoporosis. We recrulted sixty (65–75 y) women with osteoporosls (BMD T-score at the total hip or lumbar spine [L2-L4] less than −2.5 by DXA [Lunar]) from the osteoporosis clinic at British Columbia's Women's Hospital. These women were randomized to either control group or exercise group (Osteofit). Osteofit is a twice weekly, one hour long community based exercise programme for women and men with osteoporosis. It aims to reduce the participants' risk of falling and improve their functional ability by specifically using exercises that target posture, balance, galt, coordination, and hip and trunk stabilization. Baseline measures included the modified CaMos questionnaire, the mini-mental state questionnaire, the Oswestry back pain questionnaire, the quality of life questionnaire of the European Foundation for osteoporosis (QUALEFFO), quadriceps strength (seated maximal knee extension against an ankle strap incoporating strain gauge), static balance (computerized posturography [Equitest]), dynamic balance/gait (2 laps of a 20 metre figure of 8 course), height (sitting and standing) and weight. The latter seven measures were repeated at 10 weeks. There were no significant differences between the exercise and control groups at baseline for any measures. At 10 weeks, the exercise group improved significantly on Equitest while the control group did not as shown in the significant interaction (F(1,47) = 4.24, p = 0.045). There was a significant effect of time on both quadriceps strength (corrected for height)(F(1,46) = 11.99, p = 0.001) and figure of 8 (F(1,46) = 8.57, p = 0.005) in both groups. There was no significant difference in the change over time between the two groups on either quadriceps strength (Δexercise = 1.2 kg and Δcontrol = −2.6 kg) or figure of 8 (Δexercise and control = −1.2 sec). No significant difference was found on any of the five domains of QUALEFFO. These novel data suggest that a 10-week community based exercise programme significantly improves balance in 65–75 year old women with osteoporosis and thus, may reduce risk for falling.

Quality of life in patients with vertebral fractures: validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Working Party for Quality of Life of the European Foundation for Osteoporosis.

Vertebral fractures may be minor or lead to pain, decreased physical function, immobility, social isolation and depression, which together contribute to quality of life. A Working Party of the European Foundation for Osteoporosis has developed a specific questionnaire for patients with vertebral fractures. This questionnaire, QUALEFFO, includes questions in the domains pain, physical function, social function, general health perception and mental function. QUALEFFO was validated in a multicenter study in seven countries. The study was done in 159 patients aged 55-80 years with clinical osteoporosis, i.e., back pain and other complaints with at least one vertebral fracture and lumbar bone mineral density T-score <-1. Patients with a recent vertebral fracture were excluded because of unstable disease. Controls were age- and sex-matched, and did not have chronic back pain or vertebral fractures. Subjects with conditions exerting a major influence on quality of life were excluded. The QUALEFFO was administered twice within 4 weeks and compared with a generic questionnaire, the Short Form 36 of the Medical Outcomes Study (SF-36). Standard spinal radiographs were made for assessment of vertebral height. Seven questions were removed from the analysis because of low response rate, linguistic ambiguities or redundancy. The 41 remaining questions were analyzed for repeatability, internal consistency and the capacity to discriminate between patients with vertebral fractures and controls. Comparison with the SF-36 was performed within similar domains by conditional logistic regression and by receiver operating characteristic (ROC) curves. The repeatability of QUALEFFO was good (kappa statistics 0.54-0.90) and 26 of 41 questions had a kappa score >/=0.70. The internal consistency of the five domains was adequate, with Crohnbach alpha around 0.80. All except five questions discriminated significantly between patients and controls. The median scores of QUALEFFO were significantly higher in patients with vertebral fractures than in controls in all five domain (p<0. 001), which is consistent with decreased quality of life in patients with osteoporosis. Spinal radiographs were assessed using the McCloskey-Kanis algorithm. According to this, 124 patients (78%) had vertebral fractures of >/=3 SD severity, in contrast with 7 controls (4%). Significant correlations existed between scores of similar domains of QUALEFFO and the SF-36, especially for pain, physical function and mental function. All five domains within each questionnaire discriminated significantly between fracture cases and controls. The odds ratios for pain and social function were greater for QUALEFFO, while general health perception was more discriminating using the SF-36. The ROC curve analysis of QUALEFFO indicated that all five domains were significantly predictive of vertebral fractures. When comparing similar domains of the two questionnaires, QUALEFFO domains demonstrated significantly better performance for pain, physical function and social function. The QUALEFFO total score and SF-36 physical composite score showed similar performance. In conclusion, QUALEFFO is repeatable, coherent and discriminates well between patients with vertebral fractures and control subjects. The results of this study confirm the decreased quality of life in patients with vertebral fractures.